IN THE DISTRICT COURT OF APPEAL OF THE STATE OF FLORIDA

NO. 1D20-2684 IN THE DISTRICT COURT OF APPEAL OF THE STATE OF FLORIDA FIRST DISTRICT, 2000 DRAYTON DRIVE, TALLAHASSEE, FL 32399

O’DONNELL LANDSCAPES, INC., Defendant/appellant.

v.

DEPARTMENT OF HEALTH,

Plaintiff/appellee.

On Appeal from the Florida Department of Health DOH Case No.: 2020-0069

APPENDIX TO APPELLANT’S INITIAL BRIEF

__________________________

Michael C. Minardi, Esq. FLORIDA BAR NO. 568619 WM. KEVIN KILGORE, ESQ. FLORIDA BAR NO. 802890 Counsel for Appellant 5301 N. Habana Ave., Suite 3 Tampa, Florida 33614 Telephone: (813) 995-8227 Facsimile: (561) 757-7019

Filing # 122028938 E-Filed 02/24/2021 07:04:40 PM

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TABLE OF CONTENTS

Final Order Adopting Amended Presiding Officer’s Report …………...... 1 Amended Response to the Amended Order .……………………………… 2 JAPC Letter to Department ..…………..….…….…………………………. 3 Department Application Form (Form DH8013-OMMU-O8/2017) .……………………………………….. 4 Department Application Form (Form DH8013-OMMU-O4/2018) ...……………………………………… 5 OMMU Website-MMTC Applicants Proposed Rule 64-4.002 and Form (Form DH8013-OMMU-O4/2018) ...……………………………………… 6 Emergency Rule 64ER20-31 ...……………………………………… 7 Proposed Rule 64-4.001 .......……………………………………………… 8

1. Final Order Adopting Presiding Officer’s Report

2. O’Donnell Landscapes’ Response to Initial Order

3. JAPC Letter to Department

JOE NEGRON RICHARD CORCORAN

President Speaker

THE FLORIDA LEGISLATURE

JOINT ADMINISTRATIVE

PROCEDURES COMMITTEE

Representative George R. Moraitis, Jr., Chair KENNETH J. PLANTE

Senator Kevin Rader, Vice Chair COORDINATOR

Senator Daphne Campbell Room 680, Pepper Building

Senator George B. Gainer 111 W. Madison Street

Senator Rene Garcia Tallahassee, Florida 32399-1400

Senator Keith Perry Telephone (850) 488-9110

Representative Jason Fischer Fax (850) 922-6934

Representative Michael Grant www.japc.state.fl.us

Representative Sam H. Killebrew [email protected]

Representative Amy Mercado

Representative Barrington A. “Barry” Russell

October 9, 2017

Ms. Amanda G. Bush

Senior Attorney

Department of Health

Office of the General Counsel

4052 Bald Cypress Way, Bin A-02

Tallahassee, Florida 32399-1703

Re: Emergency Rule 64ER17-2

(Substantial Rewording of Rule 64-4.002, Florida Administrative Code)

Dear Ms. Bush:

I have reviewed the above-referenced emergency rule, which was filed with the Department of

State on September 19, 2017, and published in the Florida Administrative Register on

September 21, 2017. I have the following comments. The designation of the comments is based

on the numbering of the emergency rule.

64ER17-2: The title of the rule in the notice of the emergency rule is different from

the title of the rule above the rule text. Please explain which title is

correct.

Please explain why the rule and material incorporated by reference in the

rule text refer to “registration” instead of “licensure” of medical marijuana

treatment centers. See § 381.986(8)(a), Fla. Stat. (stating specifically that

medical marijuana treatment centers shall be licensed by the department);

see also § 120.52(10), Fla. Stat. (defining a license to include a

“registration”).

Ms. Amanda G. Bush

October 9, 2017

Page 2

Please explain why the introductory paragraph to this emergency rule

refers to “this regulation.” It appears it should refer to “this rule” or to

“this emergency rule.”

64ER17-2(1): This rule subsection states that, “the application [to become a medical

marijuana treatment center], once submitted to the department, shall be

considered final” and that the department will not accept any amendments

or supplements to the initial application.

Please explain which statute exempts the department from complying with

the requirements of section 120.60(1). That statute states in part:

Upon receipt of a license application, an agency shall

examine the application and, within 30 days after such

receipt, notify the applicant of any apparent errors or

omissions and request any additional information the

agency is permitted by law to require. An agency may not

deny a license for failure to correct an error or omission or

to supply additional information unless the agency timely

notified the applicant within this 30-day period. The

agency may establish by rule the time period for submitting

any additional information requested by the agency. For

good cause shown, the agency shall grant a request for an

extension of time for submitting the additional information.

If the applicant believes the agency’s request for additional

information is not authorized by law or rule, the agency, at

the applicant’s request, shall proceed to process the

application. An application is complete upon receipt of all

requested information and correction of any error or

omission for which the applicant was timely notified or

when the time for such notification has expired.

Thus, it appears the department must provide an opportunity to correct an

error or omission or supply additional information requested by the

department. If a rule and statute conflict, the statute controls. See One

Beacon Ins. v. Agency for Health Care Admin., 958 So. 2d 1127, 1129

(Fla. 1st DCA 2007) (“In cases of conflict, a statute takes precedence over

an administrative rule.”).

This subsection incorporates by reference Form DH8013-OMMU-

08/2017, Application for Medical Marijuana Treatment Center

Registration.

Ms. Amanda G. Bush

October 9, 2017

Page 3

DH8013-OMMU-08/2017:

The department is setting a page limitation for all but one section for the

narrative responses required by the application. Additionally, page two of

the application instructions states that, “Pages in excess of the page limit

will be removed from the application prior to evaluation.” Please explain

how the page limitation and the removal of pages from the application is

not arbitrary and capricious, especially when neither the rule text nor the

application advises the applicant how each item listed in each section of

the application will be weighted. See § 120.52(8)(e), Fla. Stat.

Page 2, Section 1: This section states that, “With the exception of

Sections 11, 14 and 15, Part II of the application will be evaluated using a

blind grading method and must be de-identified.” Please explain why the

headers on pages 14, 18, and 19 of Form DH8014-OMMU-08/2017,

which are the scorecards for sections 11, 14, and 15, reflect that a “Blind

Grading Number” will be assigned to those sections. It appears that this

statement conflicts with those headers.

Page 3: The form states, “The application [to become a medical marijuana

treatment center], once submitted to the department, shall be considered

final” and that the department will not accept any amendments or

supplements to the initial application. Please explain which statute

exempts the department from complying with the requirements of section

120.60(1). See comment to 64ER17-2(1) regarding the applicability of

section 120.60(1).

Page 5, A.: Please explain how documentation from the Florida

Department of Revenue demonstrates that the applicant has been

registered to do business in the state for the previous five consecutive

years.

Page 5, D., second paragraph and *NOTE: Please explain why the two

references to “Pigford Class Applicant” do not also include a reference to

the class members of In Re Black Farmers Litig. See § 381.986(8)(a)2.b.,

Fla. Stat.

Page 6, Section 1: This section is worth a total of 50 points, and the

applicant is limited to a four page narrative to address ten items. It

appears the applicant should be advised of the relative weight, percentage,

or specific number of points that the subject matter expert(s) reviewing the

application will award each applicant for each specific item to be

addressed. Also, please explain how each application is evaluated and

scored if there are no minimum thresholds or standards required for

demonstrating each item enumerated in this paragraph. See

§ 120.52(8)(d), Fla. Stat.

Ms. Amanda G. Bush

October 9, 2017

Page 4

Page 6, Section 1, Number 2.: Please explain what the department means

by “regional cultivation” and to what region the department is referring.

See § 120.52(8)(d), Fla. Stat.

Page 6, Section 1, Number 3.e.: Please explain what the department means

by “good agricultural practices.” See §§ 120.52(8)(d), .54(2)(b)2., Fla.

Stat.

Page 6, Section 1, Number 3.f.: Please explain what the department means

by “good handling practices.” See §§ 120.52(8)(d), .54(2)(b)2., Fla. Stat.

Page 6, Section 2: This section is worth 50 points, and the applicant is

limited to a seven page narrative to address eight items. See comments

regarding page 6, section 1.

Page 6, Section 2, Number 1.e.: This section asks the applicant to provide

a cultivation plan that will ensure a consistent supply of safe medical

marijuana that addresses, “Inspection processes for pests that endanger or

threaten the horticulture or agriculture of the state in accordance with

Chapter 581, Florida Statutes.” It appears this question should specify

which sections of chapter 581 the department wants addressed. See

§ 120.52(8)(d), Fla. Stat.

Page 6, Section 2, Number 1.e.: Please explain why this question does not

ask whether the applicant’s cultivation plan addresses the inspection

processes for pests that endanger or threaten the horticulture or agriculture

of the state in accordance with any rules adopted pursuant to chapter 581.

See § 381.986(8)(e)6.c., Fla. Stat. Also, it appears such rules should be

specifically identified. It appears this question may enlarge, modify, or

contravene section 381.986. See § 120.52(8)(c), Fla. Stat.

Page 6, Section 2, Number 1.f.: This question asks the applicant to

address, “Fumigation, treatment, and plant destruction plans for infested or

infected plants in accordance with Chapter 581, Florida Statutes.” It

appears this question should specify which sections of chapter 581 the

department wants addressed. See § 120.52(8)(d), Fla. Stat.

Page 6, Section 2, Number 1.f.: Please explain why this question does not

ask whether the applicant’s cultivation plan addresses fumigation,

treatment, and plant destruction plans in accordance with any rules

adopted pursuant to chapter 581. See § 381.986(8)(e)6.d., Fla. Stat. It

appears the Department of Agriculture and Consumer Services has

adopted rules pertaining to fumigation. See, e.g., Fla. Admin. Code ch.

5E-2. Also, it appears such rules should be specifically identified. It

Ms. Amanda G. Bush

October 9, 2017

Page 5

appears this question may enlarge, modify, or contravene section 381.986.

See § 120.52(8)(c), Fla. Stat.

Page 6, Section 2, Number 2.: Please explain why the department is asking

for a list of the pesticides the applicant will use for the cultivation of

medical marijuana. Section 381.986(8)(e)6.a. states that, when growing

marijuana, a medical marijuana treatment center, “[m]ay use pesticides

determined by the department, after consultation with the Department of

Agriculture and Consumer Services, to be safely applied to plants intended

for human consumption, but may not use pesticides designated as

restricted-use pesticides pursuant to s. 487.042.” It does not appear that

the department has proposed a rule stating which pesticides may be used

as required by this statute. Please explain whether the applications will be

graded on criteria that the department has not yet established by rule. See

§ 120.52(8)(d), Fla. Stat.


limited to a four page narrative to address ten items. See comments


Page 7, Section 3, Number 4.: This section asks the applicant to address its

plan to ensure compliance with federal, state, and local regulations

regarding sanitation and waste disposal.” It appears that this section

should identify the specific federal and state regulations that should be

complied with regarding solid and liquid waste disposal. Also, please

explain the department’s statutory authority to require compliance with

local regulations. It appears that section 381.986(8)(e)10.c. only requires

a medical marijuana treatment center to comply with such federal and

state laws and regulations relating to waste disposal. It does not appear

that section 381.986(11) provides an exemption to preemption to the state

regarding the disposal of solid and liquid wastes. See § 120.52(8)(c), Fla.

Stat.

Page 7, Section 3, Number 4.: Please explain why this question does not

address compliance with department rules for disposal of solid and liquid

wastes as required by section 381.986(8)(e)10.c. See § 120.52(8)(c), Fla.

Stat.

Page 7, Section 3, Number 4.: Please explain why the application does not

ask the applicant to address the “storage, handling, transportation, and

management of solid and liquid waste generated during marijuana

production and processing.” See § 381.986(8)(e)10.c., Fla. Stat.

Page 7, Section 3, Number 4.: Section 381.986(8)(e)10.c. requires the

department to “determine by rule procedures for the storage, handling,

Ms. Amanda G. Bush

October 9, 2017

Page 6

transportation, management, and disposal of solid and liquid waste

generated during marijuana production and processing” with the assistance

of the Department of Environmental Protection. It does not appear that a

rule has been proposed yet.


limited to a seven page narrative to address 13 items. See comments


Page 7, Section 4, Number 4.a.: This section requests applicants to provide

a list of proposed product offerings, and if edibles are included, requests

applicants to address the applicant’s ability or plan to obtain a permit to

operate as a food establishment in accordance with Chapter 500, Florida

Statutes. It appears that applicant should also be required to show

compliance with rules adopted pursuant to chapter 500 pursuant to

section 381.986(8)(e)8. See § 120.52(8)(c), Fla. Stat. Also, it appears

such rules should be specifically identified.

Page 7, Section 4, Number 6.: Please explain why this question asks the

applicant to submit, “A plan for utilizing extraction processes that ensure a

safe work environment (e.g., methods of extraction, use of proper

ventilation, implementation of a closed-loop system, and implementation

of Occupational Safety and Health Administration standards).” Section

381.986(8)(e)10.b. requires the department to, “determine by rule the

requirements for medical marijuana treatment centers to use [hydrocarbon

solvents or other] solvents or gases exhibiting potential toxicity to

humans.” Please explain whether the applications will be graded on

criteria that the department has not yet established by rule. See

§ 120.52(8)(d), Fla. Stat.

Page 7, Section 4, Number 7.b.: Please explain why this question requests

the applicant to submit a plan for testing medical marijuana, including, “A

list of contaminants, if any, for which the applicant will require testing.”

Section 381.986(8)(e)10.d. requires the department to, “determine by rule

which contaminants must be tested for and the maximum levels of each

contaminant which are safe for human consumption.” That statute also

requires the department, with the assistance of the Department of

Agriculture and Consumer Services, to develop, “the testing requirements

for contaminants that are unsafe for human consumption in edibles.”

Please explain whether the applications will be graded on criteria that the

department has not yet established by rule. See § 120.52(8)(d), Fla. Stat.

Page 7, Section 4, Number 7.b.: Please explain why this section does not

ask the applicant to address, “the treatment of marijuana that fails to meet

the testing requirements of this section [381.986], s. 381.988, or

Ms. Amanda G. Bush

October 9, 2017

Page 7

department rule,” which is a requirement of section 381.986(8)(e)10.d.

Furthermore, it appears that the department has not yet proposed the rule

to implement this provision as mandated by this statute.

Pages 7 and 8, Section 5: This section is worth 50 points, and the applicant

is limited to a four page narrative to address 12 items. See comments


Page 8, Section 5, Number 3.: Please explain why this question does not

address compliance with department rules for disposal of solid and liquid

wastes as required by section 381.986(8)(e)10.c. See § 120.52(8)(c), Fla.

Stat.

Page 8, Section 5, Number 3.: Please explain why the application does not

ask the applicant to address, “the storage, handling, transportation, and

management of solid and liquid waste generated during marijuana

production and processing.” See § 381.986(8)(e)10.c., Fla. Stat.

Page 8, Section 5, Number 3.: Additionally, section 381.986(8)(e)10.c.

requires the department to, “determine by rule procedures for the storage,

handling, transportation, management, and disposal of solid and liquid

waste generated during marijuana production and processing” with the

assistance of the Department of Environmental Protection. It does not

appear that a rule has been proposed yet as mandated by this statute.


limited to a five page narrative to address seven items. See comments


Page 8, Section 6, Number 2.: This question requires the applicant to

submit proposed branding, signage, and advertising documentation that

shows compliance with section 381.986(8)(h). Section 381.986(8)(h)

requires the department to approve any trade name, logo, and advertising.

Please explain whether the department will be approving any branding,

signage, and advertising using this application. Also, it appears that rules

should be adopted governing such advertising. Please explain whether the

applications will be graded on criteria that the department has not yet

established by rule. See § 120.52(8)(d), Fla. Stat.




Ms. Amanda G. Bush

October 9, 2017

Page 8

Pages 8 and 9, Section 8: This section is worth 100 points, and the

applicant is limited to an eight page narrative to address eight items. See

comments regarding page 6, section 1.

Pages 8 and 9, Section 8: Please explain why the map requested in

number 1.a. and the floor plan requested in number 1.b. will be counted

against the eight page limitation for this section. It does not appear that

that the floor plans submitted pursuant to section 9 apply to the four page

limitation set for that section.


limited to a four page narrative, plus a four page addendum, to address 16

items. See comments regarding page 6, section 1.

Page 9, Section 9, Number 1.b.: Please explain whether more than one

alarm system will be required. The scorecard refers to “alarm systems,”

for Section 9, while this section in Form DH8013-OMMU-08/2017 refers

to “alarm system.” It appears the requirement should be identical in both

documents.

Page 9, Section 9, Number 1.c.v.: Section 381.986(8)(f)1.b.(IV) requires

medical marijuana treatment centers to retain video surveillance

recordings for at least 45 days or longer upon the request of a law

enforcement agency. Please explain why this section only requires

demonstration of a plan for retention of such recordings for at least 45

days without mention of retaining the recordings longer pursuant to this

statutory requirement. See § 120.52(8)(c), Fla. Stat.

Page 9, Section 9, Number 1.d.: Section 381.986(8)(f)2. requires a

medical marijuana treatment center to ensure that its outdoor premises

have sufficient lighting from dusk until dawn. Please explain why this

section only requires the applicant’s floor plan to demonstrate that it has

outdoor lighting. See § 120.52(8)(c), Fla. Stat.




Page 10, Section 10: Also, section 381.986(8)(g)6. requires medical

marijuana treatment centers to provide specific safety and security training

to employees transporting or delivering marijuana and marijuana delivery

devices. Please explain why this section does not require applicants to

demonstrate compliance with this statutory requirement. See

§ 120.52(8)(c), Fla. Stat.

Ms. Amanda G. Bush

October 9, 2017

Page 9

Page 10, Section 10, Number 4.: This section differs from the language in

the scorecard for this section in DH8014-OMMU-08/2017, in omitting the

“or” preceding “other reasons.” It appears the language should be

identical.


applicant is limited to a six page narrative to address 21 items. See

comments regarding page 6, section 1.

Page 11, Section 11, Number 5.: Please explain what the department

means by “has a medical director at all times.” It appears this could mean,

for example, having a medical director employed, on the premises, or

available during operating hours. See § 120.52(8)(d), Fla. Stat.


limited to a four page narrative to address six items. See comments


Page 11, Section 12, Number 1.: Please explain why the second sentence

of this item is included in the application, but omitted from the scorecard

in Form DH8014-OMMU-08/2017, page 16, for this section. It appears

the language should be identical.

Page 11, Section 12, Number 3.: It appears that “key personnel” should be

defined. See § 120.52(8)(d), Fla. Stat.


limited to a four page narrative to address three items. See comments


Page 12, Section 14: Please explain why this section refers to “audited”

certified financials. It does not appear that the scorecard in Form

DH8014-OMMU-08/2017, page 16, for this section refers to “audited”

certified financials. It appears the language should be identical.


applicant is limited to an eight page narrative, plus a four page addendum,

to address 16 items. See comments regarding page 6, section 1.

Page 12, Section 15: Please explain why the language in bolded type is

included in the application but omitted from the scorecard for this section

in Form DH8014-OMMU-08/2017 on page 19.

Ms. Amanda G. Bush

October 9, 2017

Page 10

Page 12, Section 15, Number 8: It appears “hold direct or indirect

ownership or control” should be “holds direct or indirect ownership or

control.”


limited to an eight page narrative, plus a six page addendum, to address

five items. See comments regarding page 6, section 1.

Page 13, Section 16: Please explain why the “NOTE” and bolded language

in this section is not included on the scorecard for this section in Form

DH8014-OMMU-08/2017 on page 20.

Page 14, Part III: Please explain whether the department will accept

applications hand-delivered by the United States Postal Service or other

delivery services, and whether “hand delivery” is used to distinguish from

“electronic delivery.” See § 120.52(8)(d), Fla. Stat.

Page 14, Part III: See comment to 64ER17-2(1)(a) regarding the non-

refundable application fee.

64ER17-2(1)(a): Please explain why this rule paragraph states that the application fee is

non-refundable. Absent statutory authority to the contrary, it appears that

if an individual requests a refund of this fee prior to any action being taken

concerning the applicant’s qualifications, the fee should be refundable. See

Op. Att’y Gen. Fla. 75-293 (1975).

64ER17-2(1)(b): Please explain how documentation from the Florida Department of

Revenue demonstrates that the applicant has been registered to do business

in the state for the previous five consecutive years.

64ER17-2(1)(d): Please explain the department’s statutory authority to require an applicant

to be “majority-owned by (an) African-American farmer(s)” who would

otherwise meet the qualifications set forth in rule subparagraphs (1)(d)1.

through 4. Section 381.986(8)(a)2.b. requires the actual “applicant” for

such a license to be a recognized class member of Pigford v. Glickman,

185 F.R.D. 82 (D.D.C. 1999) or In Re Black Farmers Litig., 856 F. Supp.

2d 1 (D.D.C. 2011). If the applicant is only “majority-owned” (as that

term is defined in 64ER17-1(14)) by a recognized class member, it

appears this may be enlarging, modifying, or contravening section

381.986(8)(a)2.b. See § 120.52(8)(c), Fla. Stat.

64ER17-2(1)(d)3.: Please explain why the department will accept a letter from the Black

Farmers and Agriculturalists Association – Florida Chapter as evidence to

demonstrate that the applicant qualifies for registration pursuant to section

381.986(8)(a)2.b. Specifically, please explain how the Black Farmers and

Ms. Amanda G. Bush

October 9, 2017

Page 11

Agriculturalists Association – Florida Chapter can document that an

applicant was a recognized class member of Pigford v. Glickman, 185

F.R.D. 82 (D.D.C. 1999) or In Re Black Farmers Litig., 856 F. Supp. 2d 1

(D.D.C. 2011).

64ER17-2(1)(e)1.: This subparagraph describes what an applicant applying pursuant to

section 381.986(8)(a)3. must submit. One of the options that the applicant

may provide is, “documentation that the applicant currently holds or has

held a registration certificate or a citrus fruit dealer license pursuant to

sections 601.40 and 601.55, F.S, respectively.” (Emphasis added.) It does

not appear that a license held pursuant to section 601.55 is sufficient; it

appears that the applicant must also hold a registration pursuant to section

601.40.

Furthermore, it does not necessarily appear that holding registrations

pursuant to section 601.40 and section 601.55 is sufficient. It appears in

order to qualify for licensure preference pursuant to section

381.986(8)(a)3. that the applicant must be registered as a citrus processing

plant pursuant to section 601.40. See § 601.03(32), Fla. Stat. (defining

“processor” as “any person engaged in this state in the business of

canning, concentrating, or otherwise processing citrus fruit for market

other than for shipment in fresh fruit form.”). It does not appear that a

citrus packinghouse licensed pursuant to section 601.40 is eligible to

receive a licensure preference pursuant to section 381.986(8)(a)3. because

a packinghouse is a place “where citrus fruit is packed or otherwise

prepared for market or shipment in fresh form.” See § 601.03(29), Fla.

Stat. Please explain how the department will know if the applicant is

registered as a packinghouse or a processor pursuant to section 601.40.

See § 120.52(8)(c), Fla. Stat.

64ER17-2(3): Please explain which statute exempts the department from complying with

the requirements of section 120.60(1). See comment to 64ER17-2(1)

regarding the applicability of section 120.60(1).

Please explain why this subsection refers to “this regulation.” It appears it

should refer to “this rule” or “this emergency rule.”

64ER17-2(4): Unless the department publishes another emergency rule setting forth

these dates, please explain why publishing the date upon which the

department will begin accepting applications and the deadline to receive

the applications in the Florida Administrative Register and on the

department’s website is not an unadopted rule. See § 120.52(20), Fla.

Stat.

Ms. Amanda G. Bush

October 9, 2017

Page 12

64ER17-2(5): Section 381.986(8)(a) requires the department to license medical

marijuana treatment centers. Likewise, rule subsection (6) states that

licenses will be awarded, subject to availability, based on the highest total

score. The award of the licenses appears to be based on the scores

assigned by the subject matter experts referenced in this subsection.

Please advise whether these subject matter experts are department

personnel. If they are not agency personnel, please explain how this rule

is not an unauthorized delegation of the award of licenses by the

department to third parties that score various sections of the applications.

Cf. Booker Creek Preserv., Inc. v. Sw. Fla. Water Mgmt. Dist., 534 So. 2d

419, 424 (Fla. 5th DCA 1988) (“[An agency] . . . cannot delegate its

statutory duty to other state agencies.”).

This subsection incorporates by reference Form DH8014-OMMU-

08/2017, Scorecard for Medical Marijuana Treatment Center Selection.”

The title of the form provided for review is “Evaluation Rubric and

Scorecard for Medical Marijuana Treatment Center Selection.” The rule

text does not refer to the “Evaluation Rubric” in the title of the form. The

titles of the form should be consistent.

Form DH8014-OMMU-08/2017:

Page 3, Section 1: See comments regarding Section 1 of Form DH8013-

OMMU-08/2017.


OMMU-08/2017.


OMMU-08/2017.


OMMU-08/2017.


OMMU-08/2017.


OMMU-08/2017.


OMMU-08/2017.


OMMU-08/2017.

Ms. Amanda G. Bush

October 9, 2017

Page 13

Page 10, Section 8, Number 1.c.: It appears that “dispense to patient”

should be “dispense to patients.”


OMMU-08/2017.

Page 11, Section 9, Number 1.: It appears that “proposed floor plan”

should be “proposed floor plans.”

Page 11, Section 9, Number 1.b.: Please explain whether more than one

alarm system will be required. The scorecard uses “Alarm systems,” for

Section 9, while this section in Form DH8013-OMMU-08/2017 uses

“Alarm System.” It appears the requirement should be identical in both

documents.

Pages 12-13, Section 10: See comments regarding Section 10 of Form

DH8013-OMMU-08/2017.

Page 14, Section 11: See comment regarding Page 2, Section 1 of Form

DH8013-OMMU, regarding the “Blind Grading Number” header on this

section of the score card. It appears the language in the application and

the scorecard should be identical.

Pages 14-15, Section 11: See comments regarding Section 11 of Form

DH8013-OMMU-08/2017.

Page 16, Section 12: See comments regarding Section 12 of Form

DH8013-OMMU-08/2017.


DH8013-OMMU-08/2017.



section of the scorecard.


DH8013-OMMU-08/2017.



section of the score card.


DH8013-OMMU-08/2017.

Ms. Amanda G. Bush

October 9, 2017

Page 14


DH8013-OMMU-08/2017.

Page 20, Section 16, Number 4.: There is a typographical error in this

question. “[A]pplicantshas” should be “applicant has.”

64ER17-2(5)(a)1., Please explain what the department means by “advanced degree.” It is

2., 3., and 4.: unclear whether this means a post-graduate degree or whether a bachelor’s

degree will satisfy this requirement. See § 120.52(8)(d), Fla. Stat.

64ER17-2(5)(a)1.: Please explain how many subject matter experts will substantively and

comparatively review, evaluate, and score section 1, section 2, and

section 3 of the application, respectively, or alternatively whether only one

subject matter expert that meets the qualifications set forth in this

subparagraph will review each of these sections of the application. Also,

please advise whether the same subject matter expert(s) will score each of

these sections of each application. If more than one subject matter expert

is used to score the applicants, please explain how the final score is

assigned for each of these sections of the application; it appears if multiple

subject matter experts review various sections of the application, there will

be multiple scores assigned to each section. See §§ 120.52(8)(d),

.545(1)(i), Fla. Stat.

Please advise whether the subject matter experts receive any training or

guidelines as to how to substantively and comparatively review, evaluate,

and score any or all sections of the application.


comparatively review, evaluate, and score section 4 and section 5 of the

application, respectively, or alternatively whether only one subject matter

expert that meets the qualifications set forth in this subparagraph will

review each of these sections of the application. See comments above

regarding rule subparagraph (5)(a)1.


comparatively review, evaluate, and score section 6, section 7, and

section 8 of the application, respectively, or alternatively whether only one

subject matter expert that meets the qualifications set forth in this

subparagraph will review each of these sections of the application. See

comments above regarding rule subparagraph (5)(a)1.


comparatively review, evaluate, and score section 9, section 10,

section 12, and section 16 of the application, respectively, or alternatively

Ms. Amanda G. Bush

October 9, 2017

Page 15

whether only one subject matter expert that meets the qualifications set

forth in this subparagraph will review each of these sections of the

application. See comments above regarding rule subparagraph (5)(a)1.


comparatively review, evaluate, and score section 13 of the application, or

alternatively whether only one subject matter expert that meets the

qualifications set forth in this subparagraph will review this section of the


Please explain what kind of “experience working in human resources” is a

prerequisite to be a subject matter expert pursuant to this rule

subparagraph. See § 120.52(8)(d), Fla. Stat.


comparatively review, evaluate, and score section 11 of the application, or

alternatively whether only one subject matter expert that meets the

qualifications set forth in this subparagraph will review this section of the


Please explain whether the criteria to be a subject matter expert set forth in

this subparagraph as a medical doctor or as a doctor of osteopathic

medicine requires an active, unrestricted license pursuant to chapter 458 or

chapter 459.


comparatively review, evaluate, and score section 14 and section 15 of the

application, respectively, or alternatively whether only one subject matter

expert that meets the qualifications set forth in this subparagraph will

review each of these sections of the application. See comments above

regarding rule subparagraph (5)(a)1.

Please explain whether the criteria to be a subject matter expert set forth in

this subparagraph as a CPA requires an active license pursuant to

chapter 473. Also, please explain whether a person qualified to be a

subject matter expert pursuant to this subparagraph must have an active

license to practice law in Florida.

64ER17-2(5)(b): This rule paragraph states that: “Scores for each Section of the application

will be combined to create an applicant’s total score. The department

shall generate a final ranking of the applicants in order of highest to lowest

scores.” If more than one subject matter expert evaluates and scores a

section of each applications, please explain how the applications are

ranked and how the ultimate scores assigned to each section will be

Ms. Amanda G. Bush

October 9, 2017

Page 16

determined, i.e., whether the scores assigned by each subject matter expert

for each section will be averaged.

This rule paragraph states that any application that demonstrates a failure

to comply with the minimum statutory requirements for cultivation,

processing, dispensing, security, or general operations shall be denied and

will not be considered in the final ranking of applicants. If this is due to

an error or omission in the application, please explain why the applicant

will not be provided an opportunity to correct the error or omission or to

provide such additional information pursuant to section 120.60(1). See

comment to 64ER17-2(1) regarding the applicability of section 120.60(1).

Please explain what the department means by “minimum statutory

requirements for cultivation, processing, dispensing, security, or general

operations.” It appears that 381.986(8) sets forth the minimum statutory

requirements for medical marijuana treatment centers. See, e.g.,

§§ 381.986(8)(b)1.-7., Fla. Stat. (“An applicant for licensure as a medical

marijuana treatment center must demonstrate: . . . .”); 381.986(8)(e)6.a.-d.,

Fla. Stat. (stating what a medical marijuana treatment center must do when

growing marijuana). While the statutory requirements are set forth in

section 381.986(8), the application referenced in this rule paragraph

includes items that are not established in the statute. It is unclear what the

department is requiring an applicant to demonstrate to avoid having an

application denied and not considered in the final ranking of applicants.

See § 120.52(8)(d), Fla. Stat.

Please how this rule paragraph complies with the requirements of section

120.60(1). See comment to 64ER17-2(1) regarding the applicability of

section 120.60(1).

64ER17-2(6)(a): A period should be inserted at the end of this rule paragraph.

64ER17-2(6)(b): It appears that instead of referring to “applicants that own citrus and

molasses facilities,” perhaps it would be clearer to refer to rule paragraph

(5)(c) or section 381.986(8)(a)3. instead. See § 120.545(1)(i), Fla. Stat.

64ER17-2(6)(c): This rule paragraph refers to the awarding of contingent licensees and

contingent licenses. Please explain the department’s statutory authority to

award licenses contingent upon meeting the 100,000 active patient

threshold set forth in section 381.986(8)(a)4. at some unknown date in the

future. It appears that awarding such contingent licenses now could

foreclose application by certain applicants who will meet the requirements

of section 381.986(8)(b) at the time that threshold is met. It appears that

such licenses, contingent or otherwise, should not be awarded until after

Ms. Amanda G. Bush

October 9, 2017

Page 17

the 100,000 active patient threshold is reached. See § 120.52(8)(c), Fla.

Stat.

Please explain how the department ensures that any owners, officers,

board members, and managers of an applicant that is awarded a contingent

license will have continued to pass the background screening required by

section 381.986(9).

Please explain whether the provisions of section 120.60(3) apply to the

award of these contingent licenses.

64ER17-2(7)(a)4.: This rule subparagraph addresses the requisite $5 million performance

bond and states that, “The surety company can use any form it prefers for

the performance bond as long as it complies with this regulation.” It

appears this should refer to “this rule” or “this emergency rule.”

The rule text incorporates by reference Form DH8015-OMMU-08/2017,

Florida Medical Marijuana Performance Bond,” which the surety

company can use for convenience. As the conditions of the bond appear

to be included within Form DH8015-OMMU-08/2017 and not in the rule

text, please advise whether the same conditions are required if the surety

company uses a different form of the bond. See § 120.52(8)(d), Fla. Stat.

Form DH8015-OMMU-08/2017:

Second unnumbered page, Items b. and c.: Please explain the department’s

statutory authority to recover costs on behalf of anyone other than the

department, and how the department will advise patients and other

medical marijuana treatment centers that have costs attributable to the

revocation of the principal’s license that they may assign those costs and

expenses to the department. See § 120.52(8)(b) and (d), Fla. Stat.

Second unnumbered page, Item c.: It appears that “MEDICAL

MARIJUANA TREATMENT CENTER” should be “MEDICAL

MARIJUANA TREATMENT CENTERS.”

Second unnumbered page, Number 2.: It appears “nor DEPARTMENT”

should be “or DEPARTMENT.”

Second unnumbered page, Number 5.: Please explain the department’s

statutory authority to obtain an assignment of claims.

Ms. Amanda G. Bush

October 9, 2017

Page 18

Please let me know if you have any questions. Otherwise, I look forward to your response as

soon as possible.

Sincerely,

Marjorie C. Holladay

Chief Attorney

cc: Ms. Nichole C. Geary, General Counsel

Mr. Christian J. Bax, Director

Ms. Renee C. Harkins, Assistant General Counsel

MCH:SA WORD/MARJORIE/EMERGENCY RULE 17-02LS100917_#6891

4. Department Application Form (Form DH8013-OMMU-O8/2017)

STATE OF FLORIDADEPARTMENT OF HEALTH

Application for Medical MarijuanaTreatment Center Registration

This application for Medical Marijuana Treatment Center Registration (Application) is designed toallow the Florida Department of Health, Office of Medical Marijuana Use (OMMU) to select MedicalMarijuana Treatment Centers (MMTC).

This application is divided into three parts:

I. Part I requires the applicant to provide basic information about the applicant and application.II. Part II requires the applicant to provide the OMMU with detailed items to demonstrate the

ability to operate as a MMTC as set forth below in sections 1-16.

Section Title Points Page LimitI Technical Ability: Cultivation Knowledge and Experience 50 42 Technical Ability: Medical Marijuana Cultivation 50 73 Infrastructure: Cultivation 50 44 Technical Ability: Processing 100 75 Infrastructure: Processing 50 46 Technical Ability: Dispensing Operations 50 57 Technical Ability: Medical Marijuana Dispensing 50 78 Infrastructure: Dispensing 100 89 Accountability: Premises 100 410 Accountability: Operations 100 711 Personnel: Medical Director 50 6

12________

Personnel: Cultivation, Processing, Dispensing andDelivery Staff 50 4

13 Diversity Plan_______

100____________

414 Financials: Certified Financial Documents 100 No limit15 Financials: Business Structure 100 816 Infrastructure: Facilities 50 8

III. Part Ill provides information on application submittal, the required application fee, and includesthe applicant signature page.

64ER17-2(I)Effective: 08/2017Form DH8013-OMMU-08/201 7

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Application Instructions

APPLICATIONS MUST BE SAVED AS OPTICAL CHARACTER RECOGNITION PORTABLEDOCUMENT FORMAT (OCR PDF) FILES AND BE SUBMITTED ON A THUMB DRIVE.

1. Organization: When submitting an application for MMTC registration, applicants mustorganize the application so that each document submitted with the application is labeledaccurately with the section number of the application to which it corresponds.

Blind Grading

With the exception of Sections 11, 14 and 15, Part II of the application will be evaluated using ablind grading method and must be de-identified. Each application will be assigned a randomapplication number. Part II will be separated from Parts I and Ill and will be distributed to theevaluators electronically, identified only by the random application number.

It is important that Part II, Sections 1-10, 12-13, and 16 are prepared without reference to propernouns or other identifying information. Do not include the names of the business, related entities,consultant organizations, people, or other identifying information such as addresses and phonenumbers.

The jy sections that should include identifying information are Section 11 - Personnel: MedicalDirector, Section 14- Financials: Certified Financial Documents and Section 15- Financials:Business Structure.

An application that includes information that identifies the organization, consultants, entities, orpeople in Sections 1-10, 12-13 and 16 will be redacted prior to forwarding to the evaluators forgrading.

Each section must be saved as a separate file on the thumb drive. Files must be named using thefollowing format: Section Number - Section Title

Examples: Section 1 - Technical Ability: Cultivation Knowledge and ExperienceSection 2 - Technical Ability: Medical Marijuana Cultivation

Applications not submitted on thumb drives or in the required format will be denied.

2 Page Limit: Narrative responses must be double-spaced and written in Times New Roman, 12point font with 1 -inch margins. Applicants are required to abide by the page limits for each section.Pages in excess of the page limit will be removed from the application prior to evaluation.

3. Addendums: Sections 9, 15 and 16 allow for the submission of specific documentation suchas leases or property sketches, or other information that would be difficult to express in a narrativeresponse, such as photographs, maps, diagrams, or blueprints. Such documents may besubmitted as addendums, as indicated in those sections. Addendums must be included with thesection that they support and do not count against that section's page limit.

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Addendums are not an opportunity for applicants to provide additional narrative responsesin excess of a section's page limit. Additional narrative responses provided in addendumswill be removed prior to evaluation and will not be considered.

THE APPLICATION, ONCE SUBMITTED TO THE DEPARTMENT SHALL BE CONSIDEREDFINAL. THE DEPARTMENT WILL NOT ACCEPT ANY AMENDMENTS OR SUPPLEMENTS TOTHE INITIAL APPLICATION.

4. Redactions and Public Records Law: Applications are public records. Any exemptions topublic records laws must be identified at the time the application is submitted. In order to claim apublic records exemption, the applicant must provide a redacted copy of the application with thestatutory basis for each exemption clearly identified.

UNLESS INFORMATION FALLS UNDER ANOTHER PUBLIC RECORDS EXEMPTION,FAILURE TO SPECIFICALLY AND CLEARLY IDENTIFY INFORMATION CLAIMED ASEXEMPT DUE TO BEING A TRADE SECRET OR FAILURE TO PROVIDE A REDACTED COPYOF THE APPLICATION AT THE TIME OF SUBMISSION WILL RESULT IN THE RELEASE OFTHE FULL APPLICATION IN RESPONSE TO PUBLIC RECORDS REQUESTS.

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Part IApplicant:

Name:(Name must be the same as the name registered with the state)

Dept. of Agriculture Certificate Address:__________________________________________________________________

Street Address City ZIP Code

Mailing Address (if different):Street Address City ZIP Code

Contact Name:

Phone Number:______________

Medical Director:

Name:___________________

Mailing Address:______________

Street Address

Phone Number:

Florida MD or DO License Number:

64ER17-2(1)Effective: 08/2017Form DH8OI 3-OMMU-08/201 7

Email Address:

City ZIP Code

Email Address:

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A. Provide certified documentation from the Florida Department of State or FloridaDepartment of Revenue, as applicable under Florida law, demonstrating that theapplicant has been registered to do business in the state of Florida for the previous 5consecutive years.

B. Provide a certified copy of a valid certificate of registration used by the Department ofAgriculture and Consumer Services pursuant to section 581 .131, Florida Statutes.

C. Provide a list of all owners, managers, officers, and board members indicating the dateof each individual's most recent level -2 background screening. With each name, includetheir position or proposed position in the proposed MMTC.

D. Is the applicant applying as a recognized class member of Pigford v. Glickman, 185F.R.D. 82 (D.D.C. 1999) ("Pigford") or In Re Black Farmers Discrimination Litig., 856 F.Supp. 2d I (D.D.C. 2011) ("BFDL") and a member of the Black Farmers andAgriculturalists Association-Florida Chapter (Pigford Class Applicant)?

DYes DNo

If yes has been selected, provide documentation evidencing membership in the BlackFarmers Agriculturalists Association- Florida Chapter and qualification as a classmember in Pigford or BFDL. If the Applicant is only applying for licensure as a PigfordClass Applicant, the Applicant does not need to provide the documents set forth initems A and B above.

* Note that if the Applicant wishes to be considered as both a Pigford Class Applicantand a general Applicant, the Applicant must submit the documentation set forth in itemsA through D above.

E. Does the Applicant own one or more facilities that are, or were, used for the canning,concentrating, or otherwise processing of citrus fruit or citrus molasses and will use orconvert the facility or facilities for the processing of medical marijuana?

DYes DNo

If yes has been selected, provide ownership documentation, certification from theFlorida Department of Citrus and a description of how the property will be used.


Part IIResponses to this part must be in accordance with the instructions set forth on pages 2-3.

Section 1 - Technical Ability: Cultivation Knowledge and Experience (50 points, 4 page limit)

1. Experience and knowledge related to:a. Introducing new varieties of plants in Florida andb. Cultivating plants not native to the state of Florida.

2. Regional cultivation knowledge and experience, including growing in high humidityenvironments.

3. Experience and knowledge related to:a. In-house propagation;b. Genetic modification or breeding;c. Using clean growing rooms;d. Cultivating plants for human consumption such as food or medicine products;e. Good agricultural practices;f. Good handling practices; andg. Tracking each plant in a harvest.

Section 2- Technical Ability: Medical Marijuana Cultivation (50 points, 7 page limit)

1. Provide a cultivation plan that will ensure a consistent supply of safe medical marijuana forpatients that addresses:

a. The applicant's experience cultivating medical marijuana;b. The proper conditions and techniques for cultivating medical marijuana;c. The pests, diseases, and deficiencies common for medical marijuana;d. The steps the applicant will take to ensure a sanitary and safe cultivation facility;e. Inspection processes for pests that endanger or threaten the horticulture or agriculture

of the state in accordance with Chapter 581, Florida Statutes; andf. Fumigation, treatment, and plant destruction plans for infested or infected plants in

accordance with Chapter 581, Florida Statutes.2. Provide a list of the strains, additives, pesticides, fungicides, and herbicides the applicant will

use for the cultivation of medical marijuana.3. Provide a description of one or more strains of medical marijuana the applicant intends to

cultivate.

Section 3 - Infrastructure: Cultivation (50 points, 4 page limit)

1. Provide a description of the applicant's planned cultivation infrastructure including thefollowing:

a. Communication systems;b. Facility odor mitigation; andc. Back-up systems for all cultivation systems.

2. A description of the areas proposed for the cultivation of medical marijuana, including thefollowing:

a. Capacity, in square feet of growing area;

64ER17-2(1)Effective: 08/2017Form DH8013-OMMU-08/201 7 Page 6 of 14

b. An enclosed cultivation environment, e.g., indoor greenhouse, clean room, aseptic, etcetera;

c. Irrigation system(s);d. Environmental control system(s); ande. Separation from the cultivation of other plants.

3. Access to water resources that allow for sufficient irrigation.4. A plan to ensure compliance with federal, state, and local regulations regarding sanitation and

waste disposal.

Section 4- Technical Ability: Processing (100 points, 7 page limit)

1. Experience and knowledge related to:a. Good manufacturing practices andb. Analytical chemistry, organic chemistry, and microbiology.

2. A plan to ensure a sanitary and safe processing facility.3. Experience and knowledge related to:

a. Medical marijuana extraction techniques;b. Medical marijuana routes of administration; andc. Producing medical marijuana products.

4. A list of proposed product offerings which must include at least one low-THC product. If ediblesare included in the product offerings, address applicant's:

a. Ability or plan to obtain a permit to operate as a food establishment in accordance withChapter 500, Florida Statutes; and

b. Control systems to regulate the milligrams of THC in each edible and maintain potencyvariances of no greater than 15 percent; and

5. Ability or plan to pass a Food Safety Good Manufacturing Practices inspection within twelvemonths of licensure.

6. A plan for utilizing extraction processes that ensure a safe work environment (e.g.. methods ofextraction, use of proper ventilation, implementation of a closed-loop system, andimplementation of Occupational Safety and Health Administration standards).

7. A plan for testing medical marijuana, including:a. Relationship(s) with an independent laboratory(ies) andb. A list of contaminants, if any, for which the applicant will require testing.

Section 5- Infrastructure: Processing (50 points, 4 page limit)

1. Provide a description of the applicant's planned processing infrastructure, including thefollowing:

a. Communication systems;b. Odor mitigation;c. Back-up systems for all processing systems;d. Computer systems and software;e. Ventilation and exhaust system; andf. Processing area that is enclosed and separate from other plants and/or products.

2. Provide a description of the areas proposed for the processing of derivative products, includingthe following:

a. Extraction equipment and location;b. Concentration equipment and location;c. Analytical equipment, including separators and detectors, and location;

64ER17-2(1)Effective: 08/2017Form 0H8013-OMMU-08/2017 Page 7 of 14

d. Safety equipment, facilities and location; ande. Access to sufficient potable water and hot water.

3. A plan to ensure compliance with federal, state, and local regulations regarding sanitation andwaste disposal.

Section 6- Technical Ability: Dispensing Operations (50 points, 5 page limit)

1. Experience and knowledge related to:a. Supply chain management;b. Operation of multiple storefronts simultaneously;c. Operating a business in a heavily regulated environment; andd. Any other relevant business operations experience.

2. A marketing plan, including proposed branding, signage, as well as sources the applicantplans to use for advertising including documentation that the plan is compliant with the signageand Internet marketing restrictions set forth in section 381 .986(8)(h), Florida Statutes.

3. A plan for alternative dispensing, e.g., delivery.4. A de-identified mockup or branding sample for both a low-THC and a full strength product.

Section 7- Technical Ability: Medical Marijuana Dispensing (50 points, 7 page limit)

1. Knowledge and experience related to:a. Interaction with patients;b. Handling confidential information including the ability to keep records in a location not

visible to other patients; andc. Gathering and managing data, i.e., data on patient reactions to products dispensed.

2. Provide a plan for product offering including:a. Ensuring multiple options of routes of administration, including low-THC options;b. Ensuring consistent dosing; andc. De-identified packaging and labeling that do not appeal to children.

3. Provide a plan for employee training and education on topics such as:a. Patient confidentiality;b. Regulatory compliance including dispensing requirements;c. Patient education;d. Data collection; ande. Safety and security for those employees involved in transportation.

4. Provide a plan for patient education on topics such as:a. Safe use;b. Legal use;c. Safe storage; andd. Accidental ingestion.

5. Provide a plan to ensure that employees verify that all qualified patients and caregivers havean active profile in the Medical Marijuana Use Registry and have the required MedicalMarijuana Use identification cards.

6. De-identified patient testimonials related to the efficacy of the product(s) applicant intends tooffer may be included.

Section 8 - Infrastructure: Dispensing (100 points, 8 page limit)

1. Provide a description of the applicant's dispensing infrastructure, including the following:


a. A map showing the location of the applicant's proposed dispensing facilities;b. A floor plan of the actual or proposed building or buildings where dispensing activities

will occur, showing:i. Areas designed to protect patient privacy, including the provision of an

appropriately-sized waiting room and at least one private patient consultationroom, and

ii. Areas designed for retail sales.c. Description of a computer network with patient confidentiality security protocols that will

be utilized by all facilities that dispense to patients or take patient orders;d. Communication systems; ande. Hours of operation of each dispensing facility.

2. Provide a description of the methods proposed for the dispensing of medical marijuana andderivative products, including the following:

a. Accessibility of dispensing facilities, e.g., centrally located to several populated areas,located on a main roadway, not in a high crime area, et cetera, and

b. The proximity of dispensing facilities to patient populations.

Section 9 -Accountability: Premises (100 points, 4 page limit)

1. A floor plan of each cultivation, processing, dispensing, and delivery facility or proposed floorplans for proposed facilities demonstrating security measures, including the following:

a. Locking options for each means of ingress and egress;b. Alarm system that:

i. Secures all entry points and perimeter windows andii. Is equipped with motion detectors, pressure switches and duress, panic, and

hold-up alarms.c. Video surveillance system that:

i. Records continuously 24 hours per day;ii. Has cameras in fixed places that allow for the clear identification of persons and

activities in the controlled areas of the premises including grow rooms,processing rooms, storage rooms, disposal rooms/areas and point of sale rooms;

iii. Has cameras fixed in all entrances and exits to the premises which record bothindoor and outdoor and ingress and egress vantage points;

iv. Has the capability of recording clear images and displays the time and date ofthe recording;

v. Demonstrates a plan for retention of recordings for at least 45 days.d. Outdoor lighting;e. Name and function of each room; andf. Layout and dimensions of each room.

2. A storage plan for each cultivation, processing, dispensing, and delivery facility, including thefollowing:

a. Safes;b. Vaults;c. Climate control;d. Plans to ensure all medical marijuana is stored in a secured locked room or vault; ande. Plans to ensure at least 2 security personnel are on the premises where cultivation,

processing and storage occur, at all times.Applicants may provide floor plans to demonstrate the security measures required by thissection as addendums. Floorplans submitted as addendums are limited to 4 pages.


Section 10 -Accountability: Operations (100 points, 7 page limit)

1. Diversion and trafficking prevention procedures, including:a. A plan for tracking and securing medical marijuana throughout an applicant's supply

chain, which includes a seed -to-sale system;b. Description of an inventory control system for medical marijuana and derivative

products;c. If vaping products containing flower are included in the product offerings, include

information related to the tamper-proof nature of the receptacle;d. A description of personnel qualifications and experience with chain of custody or other

tracking mechanisms;e. A description of personnel reserved solely for security purposes;f. A description of personnel reserved solely for inventory control purposes; andg. A waste disposal plan.

2. A transportation plan, including:a. Proposed vehicles to be utilized for MMTC business, including transporting between an

MMTC's facilities and delivering to patients;b. Vehicle tracking systems;c. Vehicle security systems, including plan to incorporate separate locking compartments

to store any medical marijuana product or delivery devices;d. Vehicle maintenance plan; ande. The use of transportation manifests that:

i. Are generated from the seed -to-sale tracking system;ii. Include the:

1. Departure date;2. Name, location, address and license number of the originating MMTC;3. Quantity and form of product to be delivered;4. Arrival date and estimated time of arrival;5. Delivery vehicle make and model and license plate number; and6. Name and signature of the employee delivering the product.

iii. Are retained for at least 3 years.f. Requirement that at least two persons are in the vehicle when transporting medical

marijuana or medical marijuana delivery devices.3. Methods of screening and monitoring employees, including a plan to ensure all owners,

managers, board members, officers and employees are in compliance with the statutoryrequirement to clear the background screening requirement of section 381.986, FloridaStatutes.

4. A plan for the recall of any medical marijuana or derivative products that have a reasonableprobability of causing adverse health consequences based on a testing result, bad patientreaction, other reasons, and edibles which fail to meet the potency requirements of section381 .986, Florida Statutes.

5. Policies and procedures for recordkeeping.6. An emergency management plan.

Section 11 - Personnel: Medical Director (50 points, 6 page limit)

PLEASE NOTE THATAPPLICANTS ARE PERMITTED TO DESIGNATE ONLY ONE MEDICALDIRECTOR. RESPONSES TO THIS SECTION SHOULD BE RELATED TO THE MEDICAL


DIRECTOR LISTED IN PART I OF THIS APPLICATION ONLY. INFORMATION REGARDINGADDITIONAL PHYSICIAN INVOLVEMENT CAN BE INCLUDED IN SECTION 12 OF THEAPPLICATION.

1. Specialty area, if any.2. Experience or knowledge of the following:

a. Treatment of patients suffering from: cancer, epilepsy, glaucoma, positive status forhuman immunodeficiency virus (HlV), acquired immune deficiency syndrome (AIDS),post-traumatic stress disorder (PTSD), amyotrophic lateral sclerosis (ALS), Crohn'sdisease, Parkinson's disease, or multiple sclerosis;

b. Treatment of patients suffering from terminal conditions;c. Good manufacturing practices;d. Analytical and organic chemistry;e. Analytical laboratory methods;f. Analytical laboratory quality control, including a chain of custody;g. Recognizing and treating drug dependency and addiction;h. Diagnosing and treating marijuana use disorder;i. Experience with clinical trials or observational studies; andj. Experience with dispensing medications.

3. Experience or knowledge related to the following:a. The recommendation of medical marijuana for patients;b. Extraction techniques;c. Medical marijuana routes of administration;d. Producing medical marijuana products, ande. Botanical medicines.

4. Description of how the medical director will supervise the activities of the applicant, includingpatient education on topics such as safe use, accidental ingestion, and the effects of use whilepregnant or nursing.

5. Description of how the applicant will ensure it has a medical director at all times.6. Description of how the applicant will ensure that its medical director will not order medical

marijuana for patients.7. Description of how the applicant will ensure that its medical director, and other owners,

managers, and employees will refrain from engaging in any conflict of interests with orderingphysicians, including kickbacks or entering into other inappropriate relationships.

8. A copy of the proposed medical director's CV or resume.

Section 12- Personnel: Cultivation, Processing, Dispensing, and Delivery Staff (50 points, 4page limit)

1. Provide an organizational chart illustrating the supervisory structure of the applicant, includingall owners, officers, board members, managers, and employees. Supervisory positions on theorganizational chart should match the positions, or proposed positions, identified in Part I, C.on page 5 of this application.

2. Provide a list of current and proposed staffing, including:a. Position, duties, and responsibilities;b. Professional licensure disciplinary action in all jurisdictions; andc. Any awards, recognition, or relevant experience.

3. Provide plans and procedures for loss of key personnel.4. Provide plans for alcohol and drug-free work place.

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Section 13 - Diversity Plan (100 points, 4 page limit)

1. Provide a plan to ensure the involvement of minority persons, minority businesses, or veteranbusiness enterprises in ownership, management, and employment that includes therepresentation of minority persons and veterans in the proposed medical marijuana treatmentcenter's workforce.

2. Provide a plan to recruit minority persons and veterans for employment.3. Provide a plan for entering into contracts for services with minority business enterprises and

veteran business enterprises.

Section 14- Financials: Certified Financial Documents (100 points, no page limit)

Provide audited, certified financials of the applicant issued within the immediately preceding 12months.

a. Certified financials must be the applicant's. Certified financials for parent companies,subsidiaries, or other entities that are not the applicant itself will not be accepted.

b. There is no page limit for this section. However, ppjy the certified financial statementsmay be submitted. Any additional materials that are not part of the certified financialswill be removed and not considered in scoring.

Section 15- Financials: Business Structure (100 points, 8 page limit)

1. Provide an explanation of the applicant's corporate structure, including:a. The applicant's business form;b. All owners of the applicant;c. All individuals and entities that can exercise control of the applicant;d. All individuals and entities that share in the profits and losses of the applicant;e. All subsidiaries of the applicant;f. Any other individuals or entities for which the applicant is financially responsible;g. A description of the assets and liabilities of the applicant and the applicant's

subsidiaries; andh. Any pending lawsuits to which the applicant is a party.

2. Any lawsuits within the past 7 years to which the applicant was a party.3. All financial obligations of the applicant that are not listed as a "liability" in the certified

financials; including loans, notes, or any other debt that could be converted to ownership in theapplicant.

4. A projected two-year budget.5. A description of the ability or plan to expand any of the areas proposed for processing medical

marijuana.6. Specific documentation of sufficient assets available to support the projected two-year budget,

including any plans for additional expansion.7. A statement that the applicant is not associated with any other MMTC application and that no

owner, officer, board member, or manager is associated with any other MMTC application.8. A statement identifying whether the applicant, and any individual or entity that owns, controls,

or holds power to vote 5 percent of more of the voting shares of the proposed MMTC holddirect or indirect ownership or control of voting shares of any other MMTC.


9. Details regarding any contracts for services or proposed contracts for services that are directlyrelated to the cultivation, processing, or dispensing of medical marijuana or medical marijuanadelivery devices.

Applicant may provide specific documentation ofsufficient assets available to support theprojected two-year budget as an addendum, not to exceed 4 pages. This addendum does notcount against the page limit of this section. Documentation regarding applicant's businessstructure must support the response to this section and may not be used to supply additionalnarrative response.

Section '16 - Infrastructure: Facilities (50 points, 8 page limit)

1. Provide a list including the locations of all properties the applicant plans to utilize to cultivate,process, and dispense medical marijuana or derivative products, if selected. Designatewhether properties are owned or leased. For each property, list the property owner and anymortgagee and attest that each owner and mortgagee assents to the use of the property forthe purposes of operating an MMTC.

NOTE: Successful applicants will be required to provide documentation that they have movedforward with securing the properties identified in their application. Failure to meet therepresentations made in the application for MMTC approval is grounds for revocation.2. Provide a sketch or other illustration approximating the property boundaries, land topography,

vegetation, proposed and/or existing structures, easements, wells, and roadways for eachproperty proposed that will be utilized in cultivating, processing, and dispensing medicalmarijuana or derivative products.

3. Provide evidence of preliminary pre-approval for zoning for all proposed properties that will beutilized for cultivation.

4. Provide a statement acknowledging that there are no proposed dispensing locations within 500feet of a public or private school, or that the applicant has obtained or is likely to obtain theapproval of the appropriate municipality.

5. Provide a statement acknowledging that licensed MMTCs may not enter into profit sharingagreements with property owners or lessors.

Applicants may provide sketches of land that will be utilized for cultivation, processing, ordispensing and proof ofzoning as addendums to this section, not to exceed 6 pages.Ownership documentation, sketches, and proof of zoning submitted as addendums do notcount against the page limit for this section. Information in any addendum to this section mustsupport the response to this section and may not be used to supply additional narrativeresponse.

64ER17-2(1)Effective: 08/2017Form DH8OI 3-OMMU-08/2017 Page 13 of 14

Part IIICompleted applications must be hand delivered to the Department of Health at 4052 BaldCypress Way, Tallahassee, Florida 32399, during normal business hours, but no earlier than10:00 a.m., Eastern Time, on the date the Department of Health begins accepting applicationsand no later than 5:00 p.m., Eastern Time, on the last date upon which the applications areaccepted. Applications submitted after 5:00 PM Eastern Time on the final day of theapplication period will be denied.

The application MUST include:

1. A non-refundable $60,830.00 application fee in the form of a money order or cashier's checkmade payable to the Florida Department of Health;

2. A list of ALL materials for which the applicant claims ANY public records exemption, includinga specific legal citation to the exemption; and

3. A full proposed redacted version of the application, if applicable.

The completed application, along with supporting documents must be submitted on a thumbdrive. Applications submitted in hard copy form will be denied.

The undersigned applicant/representative hereby agrees to operate the MMTC described in thisapplication in accordance with the requirements of section 381.986, Florida Statutes, and allDepartment of Health rules and regulations.

The information contained in this application and the attached addendums required, which serves asa basis for licensure, is true and correct. I understand that any misrepresentation of the facts in thisapplication, or failure to comply with the requirements of statutes, regulations, and rules, is groundsfor denial or revocation of Medical Marijuana Treatment Center approval. I understand that knowinglymaking a false statement in writing with the intent to mislead a public servant in the performance ofhis or her official duty is guilty of a misdemeanor of the second degree, punishable as provided insections 775.082 or 775.083, Florida Statutes.

Signature of Applicant/Representative Date

Name of Applicant/Representative (print or type):

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5. Department Application Form

(Form DH8013-OMMU-O4/2018)

Rule 64-4.002, F.A.C. Effective: 04/2018 Form DH8013-OMMU-04/2018

STATE OF FLORIDA

DEPARTMENT OF HEALTH

Application for Medical Marijuana

Treatment Center Registration

This application for Medical Marijuana Treatment Center Registration (Application) is designed to allow the Florida Department of Health, Office of Medical Marijuana Use (OMMU) to select Medical Marijuana Treatment Centers (MMTC).

This application is divided into three parts:

I. Part I requires the applicant to provide basic information about the applicant and application. II. Part II requires the applicant to provide the OMMU with detailed items to demonstrate the

ability to operate as a MMTC as set forth below in sections 1-16.

Section Title Points Page Limit

1 Technical Ability: Cultivation Knowledge and Experience 50 4

2 Technical Ability: Medical Marijuana Cultivation 50 7

3 Infrastructure: Cultivation 50 4

4 Technical Ability: Processing 100 7

5 Infrastructure: Processing 50 4

6 Technical Ability: Dispensing Operations 50 5

7 Technical Ability: Medical Marijuana Dispensing 50 7

8 Infrastructure: Dispensing 100 8

9 Accountability: Premises 100 4

10 Accountability: Operations 100 7

11 Personnel: Medical Director 50 6

12 Personnel: Cultivation, Processing, Dispensing and Delivery Staff

50 4

13 Diversity Plan 100 4

14 Financials: Certified Financial Documents 100 No limit

15 Financials: Business Structure 100 8

16 Infrastructure: Facilities 50 8

III. Part III provides information on application submittal, the required application fee, and includes

the applicant signature page.

Rule 64-4.002, F.A.C. Effective: 04/2018 Form DH8013-OMMU-04/2018 Page 2 of 14

Application Instructions

APPLICATIONS MUST BE SAVED AS OPTICAL CHARACTER RECOGNITION PORTABLE DOCUMENT FORMAT (OCR PDF) FILES AND BE SUBMITTED ON A USB FLASH DRIVE.

1. Organization: When submitting an application for MMTC registration, applicants must organize the application so that each document submitted with the application is labeled accurately with the section number of the application to which it corresponds.

Blind Grading With the exception of Sections 11, 14 and 15, Part II of the application will be evaluated using a blind grading method and must be de-identified. Each application will be assigned a random application number. Part II will be separated from Parts I and III and will be distributed to the evaluators electronically, identified only by the random application number. It is important that Part II, Sections 1-10, 12-13, and 16 are prepared without reference to proper nouns or other identifying information for individuals and business entities. The only sections that should include identifying information are Section 11 – Personnel: Medical Director, Section 14 – Financials: Certified Financial Documents and Section 15 – Financials: Business Structure. An application that includes information that identifies the organization, consultants, entities, or people in Sections 1-10, 12-13 and 16 will be redacted prior to forwarding to the evaluators for grading. Each section must be saved as a separate file on the USB flash drive. Files must be named using the following format: Section Number – Section Title

Examples: Section 1 – Technical Ability Cultivation Knowledge and Experience Section 2 – Technical Ability Medical Marijuana Cultivation Applications not submitted on USB flash drives or in the required format will be denied. 2. Page Limit: Narrative responses must be double-spaced and written in Times New Roman, 12 point font with 1-inch margins. Applicants are required to abide by the page limits for each section. Pages in excess of the page limit will be removed from the application prior to evaluation.

3. Addendums: Sections 8, 9, 15 and 16 allow for the submission of specific documentation such as leases or property sketches, or other information that would be difficult to express in a narrative response, such as photographs, maps, diagrams, or blueprints. Such documents may be submitted as addendums, as indicated in those sections. Addendums must be included with the section that they support and do not count against that section’s page limit.

Addendums are not an opportunity for applicants to provide additional narrative responses in excess of a section’s page limit. Additional narrative responses provided in addendums will be removed prior to evaluation and will not be considered.


4. Redactions and Public Records Law: Applications are public records. Any exemptions to public records laws must be identified at the time the application is submitted. In order to claim a public records exemption, the applicant must provide a redacted copy of the application with the statutory basis for each exemption clearly identified. UNLESS INFORMATION FALLS UNDER ANOTHER PUBLIC RECORDS EXEMPTION, FAILURE TO SPECIFICALLY AND CLEARLY IDENTIFY INFORMATION CLAIMED AS EXEMPT AS A TRADE SECRET OR FAILURE TO PROVIDE A REDACTED COPY OF THE APPLICATION AT THE TIME OF SUBMISSION WILL RESULT IN THE RELEASE OF THE FULL APPLICATION IN RESPONSE TO PUBLIC RECORDS REQUESTS.


Part I

Applicant:

Name: ________________________________________________________________________________________ (Name must be the same as the name registered with the state)

Florida Department of Agriculture Certificate of Registration Address:


Mailing Address (if different):


Contact Name: ________________________________________________ Phone Number: _____________________________ Email Address: _____________________________________

Medical Director:

Name of Medical Director Employed by the MMTC:_____________________________________________________ Mailing Address: ________________________________________________________________________________


Phone Number: _____________________________ Email Address: _____________________________________

Florida MD or DO License Number: ____________________________________________


A. Provide certified documentation from the Florida Department of State or Florida Department of Revenue, as applicable under Florida law, demonstrating that the applicant has been registered to do business in the state of Florida for the previous five (5) consecutive years.

B. Provide a certified copy of a valid certificate of registration used by the Department of

Agriculture and Consumer Services pursuant to section 581.131, Florida Statutes.

C. Provide a list of all owners, managers, officers, and board members indicating the date of each individual’s most recent level-2 background screening. With each name, include their position or proposed position in the proposed MMTC.

D. Is the applicant applying as a recognized class member of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999) (“Pigford”) or In Re Black Farmers Discrimination Litig., 856 F. Supp. 2d 1 (D.D.C. 2011) (“BFDL”) (Pigford Class Applicant)?

☐ Yes ☐ No

If yes has been selected, provide documentation evidencing qualification as a class member in Pigford or BFDL. If the applicant is only applying for licensure as a Pigford Class Applicant, the Applicant does not need to provide the documents set forth in item B above. * Note that if the applicant wishes to be considered as both a Pigford Class Applicant and a general applicant, the applicant must submit the documentation set forth in items A through D above.

E. Does the applicant own one or more facilities that are, or were, used for the canning, concentrating, or otherwise processing of citrus fruit or citrus molasses and will use or convert the facility or facilities for the processing of medical marijuana?

☐ Yes ☐ No

If yes has been selected, provide ownership documentation, certification from the Florida Department of Citrus and a description of how the property will be used.


Part II

Responses to this part must be in accordance with the instructions set forth on pages 2 – 3.

Section 1 – Technical Ability: Cultivation Knowledge and Experience (50 points, 4 page limit)

1. Experience and knowledge related to: a. Introducing new varieties of plants in Florida and b. Cultivating plants not native to the state of Florida.

2. Regional cultivation knowledge and experience, including growing in high humidity environments.

3. Experience and knowledge related to: a. In-house propagation; b. Genetic modification or breeding; c. Using clean growing rooms; d. Cultivating plants for human consumption such as food or medicine products; e. Good agricultural practices; f. Good handling practices; and g. Tracking each plant in a harvest.

Section 2 – Technical Ability: Medical Marijuana Cultivation (50 points, 7 page limit)

1. Provide a cultivation plan that will ensure a consistent supply of safe medical marijuana for patients that addresses:

a. The applicant’s experience cultivating medical marijuana; b. The proper conditions and techniques for cultivating medical marijuana; c. The pests, diseases, and deficiencies common for medical marijuana; d. The steps the applicant will take to ensure a sanitary and safe cultivation facility; e. Inspection processes for pests that endanger or threaten the horticulture or agriculture

of the state in accordance with Chapter 581, Florida Statutes; f. Fumigation, treatment, and plant destruction plans for infested or infected plants in

accordance with Chapter 581, Florida Statutes; g. The additives, pesticides, fungicides, and herbicides the applicant intends to use for the

cultivation of medical marijuana; and h. A description of one or more strains of low-THC cannabis and medical marijuana the

applicant intends to cultivate. Section 3 – Infrastructure: Cultivation (50 points, 4 page limit)

1. Provide a description of the applicant’s planned cultivation infrastructure including the following:

a. Communication systems; b. Facility odor mitigation; and c. Back-up systems for all cultivation systems.

2. A description of the areas proposed for the cultivation of medical marijuana, including the following:

a. Capacity, in square feet of growing area;


b. An enclosed cultivation environment, e.g., indoor greenhouse, clean room, aseptic, et cetera;

c. Irrigation system(s); d. Environmental control system(s); and e. Separation from the cultivation of other plants.

3. Access to water resources that allow for sufficient irrigation. 4. A plan to ensure compliance with federal, state, and local regulations regarding sanitation and

waste disposal, including procedures for the storage, handling, transportation, and management of solid and liquid waste generated during medical marijuana production.

Section 4 – Technical Ability: Processing (100 points, 7 page limit) 1. Experience and knowledge related to:

a. Good manufacturing practices and b. Analytical chemistry, organic chemistry, and microbiology.

2. A plan to ensure a sanitary and safe processing facility. 3. Experience and knowledge related to:

a. Medical marijuana extraction techniques; b. Medical marijuana routes of administration; c. Producing medical marijuana products; and d. Testing medical marijuana for potency and contaminants.

4. A list of proposed product offerings which must include at least one low-THC product. If edibles are included in the product offerings, address applicant’s:

a. Ability or plan to obtain a permit to operate as a food establishment in accordance with Chapter 500, Florida Statutes; and

b. Control systems to regulate the milligrams of THC in each edible and maintain potency variances of no greater than fifteen (15) percent; and

5. Ability or plan to pass a Food Safety Good Manufacturing Practices inspection within twelve months of licensure.

6. A plan for utilizing extraction processes that ensures a safe work environment (e.g., methods of extraction, use of proper ventilation, implementation of a closed-loop system, and implementation of Occupational Safety and Health Administration standards).

7. A plan for testing medical marijuana, including: a. Testing for potency; b. Testing for contaminants; and c. A list of contaminants, if any, for which the applicant will require testing.

Section 5 – Infrastructure: Processing (50 points, 4 page limit)

1. Provide a description of the applicant’s planned processing infrastructure, including the following:

a. Communication systems; b. Odor mitigation; c. Back-up systems for all processing systems; d. Computer systems and software; e. Ventilation and exhaust system; and f. Processing area that is enclosed and separate from other plants and/or products.

2. Provide a description of the areas proposed for the processing of derivative products, including the following:


a. Extraction equipment and location; b. Concentration equipment and location; c. Analytical equipment, including separators and detectors, and location; d. Safety equipment, facilities and location; and e. Access to sufficient potable water and hot water.

3. A plan to ensure compliance with federal, state, and local regulations regarding sanitation and waste disposal, including procedures for the storage, handling, transportation, and management of solid and liquid waste generated during medical marijuana processing.

Section 6 – Technical Ability: Dispensing Operations (50 points, 5 page limit)

1. Experience and knowledge related to: a. Supply chain management; b. Operation of multiple storefronts simultaneously; c. Operating a business in a heavily regulated environment; and d. Any other relevant business operations experience.

2. A marketing plan, including proposed branding, signage, as well as sources the applicant plans to use for advertising including documentation that the plan is compliant with the signage and Internet marketing restrictions set forth in section 381.986(8)(h), Florida Statutes.

3. A plan for alternative dispensing, e.g., delivery. 4. A de-identified mockup or branding sample for both a low-THC and a full strength product.

Section 7 – Technical Ability: Medical Marijuana Dispensing (50 points, 7 page limit)

1. Knowledge and experience related to: a. Interaction with patients; b. Handling confidential information including the ability to keep records in a location not

visible to other patients; and c. Gathering and managing data, i.e., data on patient reactions to products dispensed.

2. Provide a plan for product offering including: a. Ensuring multiple options of routes of administration, including low-THC options; b. Ensuring consistent dosing; and c. De-identified packaging and labeling that do not appeal to children.

3. Provide a plan for employee training and education on topics such as: a. Patient confidentiality; b. Regulatory compliance including dispensing requirements; c. Patient education; d. Data collection; and e. Safety and security for those employees involved in transportation.

4. Provide a plan for patient education on topics such as: a. Safe use; b. Legal use; c. Safe storage; and d. Accidental ingestion.

5. Provide a plan to ensure that employees verify that all qualified patients and caregivers have an active profile in the Medical Marijuana Use Registry and have the required Medical Marijuana Use identification cards.

6. De-identified patient testimonials related to the efficacy of the product(s) applicant intends to offer may be included.


Section 8 – Infrastructure: Dispensing (100 points, 8 page limit)

1. Provide a description of the applicant’s dispensing infrastructure, including the following: a. A map showing the location of the applicant’s proposed dispensing facilities; b. A floor plan of the actual or proposed building or buildings where dispensing activities

will occur, showing: i. Areas designed to protect patient privacy, including the provision of an

appropriately-sized waiting room and at least one private patient consultation room, and

ii. Areas designed for retail sales. c. Description of a computer network with patient confidentiality security protocols that will

be utilized by all facilities that dispense to patients or take patient orders; d. Communication systems; and e. Hours of operation of each dispensing facility.

2. Provide a description of the methods proposed for the dispensing of medical marijuana and derivative products, including the following:

a. Accessibility of dispensing facilities, e.g., centrally located to several populated areas, located on a main roadway, not in a high crime area, et cetera, and

b. The proximity of dispensing facilities to patient populations. Applicants may provide floor plans to demonstrate the infrastructure required by this section as addendums. Floor plans submitted as addendums are limited to 4 pages Section 9 – Accountability: Premises (100 points, 4 page limit)

1. A floor plan of each cultivation, processing, dispensing, and delivery facility or proposed floor plans for proposed facilities demonstrating security measures, including the following:

a. Locking options for each means of ingress and egress; b. Alarm systems that:

i. Secure all entry points and perimeter windows and ii. Are equipped with motion detectors, pressure switches and duress, panic, and

hold-up alarms. c. Video surveillance system that:

i. Records continuously 24 hours per day; ii. Has cameras in fixed places that allow for the clear identification of persons and

activities in the controlled areas of the premises including grow rooms, processing rooms, storage rooms, disposal rooms/areas and point of sale rooms;

iii. Has cameras fixed in all entrances and exits to the premises which record both indoor and outdoor and ingress and egress vantage points;

iv. Has the capability of recording clear images and displays the time and date of the recording;

v. Demonstrates a plan for retention of recordings for at least 45 days. d. Outdoor lighting; e. Name and function of each room; and f. Layout and dimensions of each room.

2. A storage plan for each cultivation, processing, dispensing, and delivery facility, including the following:


a. Safes; b. Vaults; c. Climate control; d. Plans to ensure all medical marijuana is stored in a secured locked room or vault; and e. Plans to ensure at least two (2) security personnel are on the premises where

cultivation, processing and storage occur, at all times. Applicants may provide floor plans to demonstrate the security measures required by this section as addendums. Floor plans submitted as addendums are limited to 4 pages. Section 10 – Accountability: Operations (100 points, 7 page limit)

1. Diversion and trafficking prevention procedures, including: a. A plan for tracking and securing medical marijuana throughout an applicant’s supply

chain, which includes a seed-to-sale system; b. Description of an inventory control system for medical marijuana and derivative

products; c. If vaping products containing flower are included in the product offerings, include

information related to the tamper-proof nature of the receptacle; d. A description of personnel qualifications and experience with chain of custody or other

tracking mechanisms; e. A description of personnel reserved solely for security purposes; f. A description of personnel reserved solely for inventory control purposes; and g. A waste disposal plan.

2. A transportation plan, including: a. Proposed vehicles to be utilized for MMTC business, including transporting between an

MMTC’s facilities and delivering to patients; b. Vehicle tracking systems; c. Vehicle security systems, including a plan to incorporate separate locking

compartments to store any medical marijuana product or delivery devices; d. Vehicle maintenance plan; and e. The use of transportation manifests that:

i. Are generated from the seed-to-sale tracking system; ii. Include the:

1. Departure date; 2. Name, location, address and license number of the originating MMTC; 3. Quantity and form of product to be delivered; 4. Arrival date and estimated time of arrival; 5. Delivery vehicle make and model and license plate number; and 6. Name and signature of the employee delivering the product.

iii. Are retained for at least three (3) years. f. Requirement that at least two (2) persons are in the vehicle when transporting medical

marijuana or medical marijuana delivery devices. 3. Methods of screening and monitoring employees, including a plan to ensure all owners,

managers, board members, officers and employees are in compliance with the statutory requirement to clear the background screening requirement of section 381.986, Florida Statutes.

4. A plan for the recall of any medical marijuana or derivative products that have a reasonable probability of causing adverse health consequences based on a testing result, bad patient


reaction, or other reasons, and edibles which fail to meet the potency requirements of section 381.986, Florida Statutes.

5. Policies and procedures for recordkeeping. 6. An emergency management plan. Section 11 – Personnel: Medical Director (50 points, 6 page limit) PLEASE NOTE THAT APPLICANTS ARE PERMITTED TO DESIGNATE ONLY ONE MEDICAL DIRECTOR. RESPONSES TO THIS SECTION SHOULD BE RELATED TO THE MEDICAL DIRECTOR LISTED IN PART I OF THIS APPLICATION ONLY. INFORMATION REGARDING ADDITIONAL PHYSICIANS INVOLVED WITH THE MMTC CAN BE INCLUDED IN SECTION 12 OF THE APPLICATION. 1. Specialty area, if any. 2. Experience or knowledge of the following:

a. Treatment of patients suffering from: cancer, epilepsy, glaucoma, positive status for human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), post-traumatic stress disorder (PTSD), amyotrophic lateral sclerosis (ALS), Crohn’s disease, Parkinson’s disease, or multiple sclerosis;

b. Treatment of patients suffering from terminal conditions; c. Good manufacturing practices; d. Analytical and organic chemistry; e. Analytical laboratory methods; f. Analytical laboratory quality control, including a chain of custody; g. Recognizing and treating drug dependency and addiction; h. Diagnosing and treating marijuana use disorder; i. Experience with clinical trials or observational studies; and j. Experience with dispensing medications.

3. Experience or knowledge related to the following: a. The recommendation of medical marijuana for patients; b. Extraction techniques; c. Medical marijuana routes of administration; d. Producing medical marijuana products, and e. Botanical medicines.

4. Description of how the medical director employed by the applicant will supervise the activities of the applicant, including patient education on topics such as safe use, accidental ingestion, and the effects of medical marijuana use while pregnant or nursing.

5. Description of how the applicant will ensure it has a medical director at all times. 6. Description of how the applicant will ensure that its medical director will not order medical

marijuana for patients. 7. Description of how the applicant will ensure that its medical director, and other owners,

managers, and employees will refrain from engaging in any conflict of interests with ordering physicians, including kickbacks or entering into other inappropriate relationships.

8. A copy of the proposed medical director’s CV or resume. Section 12 – Personnel: Cultivation, Processing, Dispensing, and Delivery Staff (50 points, 4 page limit)


1. Provide an organizational chart illustrating the supervisory structure of the applicant, including all owners, officers, board members, managers, and employees. Supervisory positions on the organizational chart should match the positions, or proposed positions, identified in Part I, C. on page 5 of this application.

2. Provide a list of current and proposed staffing, including positions, duties, and responsibilities. Applicants may note positions that have been filled, but may not include the individual’s name. Please include the following information for filled positions:

a. Professional licensure disciplinary action in all jurisdictions; and b. Any awards, recognition, or relevant experience.

3. Provide plans and procedures for loss of key personnel. 4. Provide plans for alcohol and drug-free work place.

Section 13 – Diversity Plan (100 points, 4 page limit)

1. Provide a plan to ensure the involvement of minority persons, minority businesses, or veteran business enterprises in ownership, management, and employment that includes the representation of minority persons and veterans in the proposed medical marijuana treatment center’s workforce.

2. Provide a plan to recruit minority persons and veterans for employment. 3. Provide a plan for entering into contracts for services with minority business enterprises and

veteran business enterprises. Section 14 – Financials: Certified Financial Documents (100 points, no page limit)

1. Provide audited, certified financials of the applicant issued within the immediately preceding 12 months.

a. Certified financials must be the applicant’s. Certified financials for parent companies, subsidiaries, or other entities that are not the applicant itself will not be accepted.

b. There is no page limit for this section. However, only the certified financial statements may be submitted. Any additional materials that are not part of the certified financials will be removed and not considered in scoring.

Section 15 – Financials: Business Structure (100 points, 8 page limit)

1. Provide an explanation of the applicant’s corporate structure, including: a. The applicant’s business form; b. All owners of the applicant; c. All individuals and entities that can exercise control of the applicant; d. All individuals and entities that share in the profits and losses of the applicant; e. All subsidiaries of the applicant; f. Any other individuals or entities for which the applicant is financially responsible; g. A description of the assets and liabilities of the applicant and the applicant’s

subsidiaries; and h. Any pending lawsuits to which the applicant is a party.

2. Any lawsuits within the past seven (7) years to which the applicant was a party. 3. All financial obligations of the applicant that are not listed as a “liability” in the certified

financials; including loans, notes, or any other debt that could be converted to ownership in the applicant.

4. A projected two-year budget.


5. A description of the ability or plan to expand any of the areas proposed for processing medical marijuana.

6. Specific documentation of sufficient assets available to support the projected two-year budget, including any plans for additional expansion.

7. A statement that the applicant is not associated with any other MMTC application and that no owner, officer, board member, or manager is associated with any other MMTC application.

8. A statement identifying whether the applicant, and any individual or entity that owns, controls, or holds power to vote five (5) percent of more of the voting shares of the proposed MMTC holds direct or indirect ownership or control of voting shares of any other MMTC.

9. Details regarding any contracts for services or proposed contracts for services that are directly related to the cultivation, processing, or dispensing of medical marijuana or medical marijuana delivery devices.

Applicant may provide specific documentation of sufficient assets available to support the projected two-year budget as an addendum, not to exceed 4 pages. This addendum does not count against the page limit of this section. Documentation regarding applicant’s business structure must support the response to this section and may not be used to supply additional narrative response. Section 16 – Infrastructure: Facilities (50 points, 8 page limit)

1. Provide a list including the locations of all properties the applicant plans to utilize to cultivate, process, and dispense medical marijuana or derivative products, if selected. Designate whether properties are owned or leased.

NOTE: Successful applicants will be required to provide documentation that they have moved forward with securing the properties identified in their application. Failure to meet the representations made in the application for MMTC approval is grounds for revocation. 2. Provide a sketch or other illustration approximating the property boundaries, land topography,

vegetation, proposed and/or existing structures, easements, wells, and roadways for each property proposed that will be utilized in cultivating, processing, and dispensing medical marijuana or derivative products.

3. Provide evidence of preliminary pre-approval for zoning for all proposed properties that will be utilized for cultivation.

4. Provide a statement acknowledging that there are no proposed dispensing locations within 500 feet of a public or private school, or that the applicant has obtained or is likely to obtain the approval of the appropriate municipality.

5. Provide a statement acknowledging that licensed MMTCs may not enter into profit sharing agreements with property owners or lessors.

Applicants may provide sketches of land that will be utilized for cultivation, processing, or dispensing and proof of zoning as addendums to this section, not to exceed 6 pages. Ownership documentation, sketches, and proof of zoning submitted as addendums do not count against the page limit for this section. Information in any addendum to this section must support the response to this section and may not be used to supply additional narrative response.


Part III

Completed applications must be hand delivered to the Department of Health at 4052 Bald Cypress Way, Tallahassee, Florida 32399, during normal business hours, but no earlier than 10:00 a.m., Eastern Time, 21 days after the effective date of this rule and no later than 5:00 p.m., Eastern Time, 42 days after the effective date of this rule. Applications submitted after 5:00 p.m. Eastern Time on the final day of the application period will be denied. The application MUST include:

1. A non-refundable $60,830.00 application fee in the form of a money order or cashier’s check made payable to the Florida Department of Health;

2. A list of ALL materials for which the applicant claims ANY public records exemption, including a specific legal citation to the exemption; and

3. A full proposed redacted version of the application, if applicable. The completed application, along with supporting documents must be submitted on a USB flash drive. Applications submitted in hard copy form will be denied. The undersigned applicant/representative hereby agrees to operate the MMTC described in this application in accordance with the requirements of section 381.986, Florida Statutes, and all Department of Health rules and regulations. The information contained in this application and the attached addendums required, which serves as a basis for registration, is true and correct. I understand that any misrepresentation of the facts in this application, or failure to comply with the requirements of statutes, regulations, and rules, is grounds for denial or revocation of Medical Marijuana Treatment Center Registration. Approved medical marijuana treatment centers with an active registration must comply with all rules or regulations as they are adopted regardless of the representations made in their initial application. I understand that knowingly making a false statement in writing with the intent to mislead a public servant in the performance of his or her official duty is guilty of a misdemeanor of the second degree, punishable as provided in sections 775.082 or 775.083, Florida Statutes. ________________________________________ ________________________________ Signature of Applicant/Representative Date Name of Applicant/Representative (print or type): _________________________________________

6. OMMU Website-MMTC Applicants Proposed Rule 64-4.002 and Form (Form DH8013-OMMU-O4/2018)

7. Emergency Rule 64ER20-31

Notice of Emergency Rule


RULE NO.: RULE TITLE:

64ER20-31 Definitions

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC, HEALTH, SAFETY OR

WELFARE: Pursuant to Chapter 2020-114, § 14, Laws of Florida, the Department is not required to make findings

of an immediate danger to the public, health, safety, or welfare.

REASONS FOR CONCLUDING THAT THE PROCEDURE USED IS FAIR UNDER THE CIRCUMSTANCES:

The Department of Health is directed by Chapter 2020-114, § 14, Laws of Florida, to adopt emergency rules to

implement section 381.986, Florida Statutes.

SUMMARY OF THE RULE: Emergency Rule 64ER20-31 repeals and replaces 64ER19-4, F.A.C., and amends the

existing definitions in Rule 64-4.001, F.A.C., to update and add new definitions needed for additional rules being

promulgated at this time.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Christopher Ferguson at

[email protected].

THE FULL TEXT OF THE EMERGENCY RULE IS:

64ER20-31 (64-4.001) Definitions.

All the terms defined in section 381.986, F.S., shall have the meanings provided in that section, whenever used in

this chapter. For the purposes of Department of Health (the “department”) medical marijuana treatment center rules

and regulations, the following words and phrases shall have the following meanings indicated:

(1) AFRNP - The Applicant Fingerprint Retention and Notification Program authorized by section 943.05(2)(b),

F.S., and established by the Florida Department of Law Enforcement, as provided in Rule 11C-6.010, F.A.C.

(2)(1) Applicant – An individual or entity that meets the requirements of section 381.986(8)(b), F.S., and

applies for licensure registration as a medical marijuana treatment center pursuant to section 381.986(8)(a), F.S.,

excluding subparagraph 1. and sub-subparagraph 2.a.

(3) Arrest Report – The detailed narrative written by the arresting law enforcement officer explaining the

circumstances of the arrest.

(4) Certificate of analysis – The document created by a Certified Marijuana Testing Laboratory (CMTL) that

meets the requirements of the CMTL Certificate of Analysis rule.

(5)(2) Certified Financials – Financial statements that have been audited in accordance with Generally Accepted

Auditing Standards (GAAS) by a Certified Public Accountant, licensed pursuant to chapter 473, F.S.

(6) Child resistant – Satisfying the requirements of the United States Poison Prevention Packaging Act of 1970,

15 U.S.C. ss.1471 et seq, (1-14-2019 edition), which is incorporated by reference and available at:

https://knowthefactsmmj.com/, and any regulations adopted thereunder.

(7) Commercially manufactured food product – Ready-to-eat food products available for immediate and final

consumption.

(8)(3) Cultivation – The preparation of any soil or other medium for the planting of marijuana or the tending

and care or harvesting of marijuana intended to be dispensed by a medical marijuana treatment center for medical

use by a qualified patient.

(9)(4) Cultivation Authorization – Written notification by the department to a medical marijuana treatment

center that it may begin cultivating marijuana.

(10)(5) Cultivation Facility – Any area designated to be used for cultivation of marijuana.

(11)(6) Derivative Product – Usable product created from, infused with, or that otherwise includes or contains

marijuana. Forms of marijuana suitable for medical use.

(12)(7) Dispensing Authorization – Written notification by the department to a medical marijuana treatment

center that it may begin dispensing derivative product.

(13)(8) Dispensing Facility – Any area designated to be accessible by the public and where derivative product

and marijuana delivery devices will be dispensed at retail.

(14) Edible – Derivative product that is a commercially produced food item made with, or infused with,

marijuana oil, but no other form of marijuana, that is produced and dispensed by an MMTC. The term edible

includes any derivative product made with, or infused with, marijuana oil, that otherwise meets the definition of

“food” in section 500.03, F.S., and complies with the Standards for Production of Edibles rule. The term does not

include pills, capsules, tinctures, topicals, and similar usable products.

(15)(9) Employee – Any person whose duties involve any aspect of the cultivation, processing, transportation or

dispensing of marijuana whether or not compensated for the performance of such duties.

(16) Expiration date – the month, day, and year, as determined by the MMTC on the basis of tests or other

information showing that the edible, when stored at room temperature in a sealed receptacle, is no longer fit for

consumption or optimally fresh.

(17) FDLE - The Florida Department of Law Enforcement.

(18)(10) Financial Statements – A presentation of financial data, including accompanying notes, derived from

accounting records, that purports to show actual or anticipated financial position and intended to communicate an

entity's economic resources or obligations at a point in time, and the results of operations and cash flows for a period

of time, in accordance with generally accepted accounting principles or a comprehensive basis of accounting other

than generally accepted accounting principles. Financial presentations included in tax returns are not financial

statements. The method of preparation (for example, manual or computer preparation) is not relevant to the

definition of a financial statement.

(19) Firmly affixed – Attached such that the label is not easily removed or damaged upon opening of a

derivative product receptacle.

(20)(11) Fulfillment and Storage Facility – Any area designated, which is not open to the public, to be used for

order fulfillment, shipping, transportation, or storage of low-THC cannabis, medical marijuana, usable derivative

product or marijuana delivery devices.

(21)(12) Interests – Any form of ownership in or control of an applicant or a medical marijuana treatment

center, including, but not limited to, ownership of stock, membership interests, partnership interests, a sole

proprietorship or otherwise which convey to the holder thereof an ownership right or an interest in or right to the

profits, capital, or voting with respect to such applicant or medical marijuana treatment center.

(22) Label or labeling – The slip of paper or similar material inscribed with print or graphics and firmly affixed

to the derivative product receptacle in which usable product is dispensed or displayed.

(23) Livescan Service Provider - A vendor, entity, or agency authorized by s. 943.053(13), F.S., that scans

fingerprints electronically and submits them to FDLE.

(24)(13) Majority Ownership – Ownership of more than 50% of the interests of an applicant or medical

marijuana treatment center, such ownership being determined by application of the requirements in subsection (15),

below.

(25)(14) Manager – Any person with the authority, directly or indirectly, to exercise or contribute to the

operational control, direction or management of an applicant or a medical marijuana treatment center or who has

direct or indirect authority to supervise any employee of an applicant or a medical marijuana treatment center. The

term shall be interpreted broadly and shall include, but not be limited to, all officers, managers, and members of

board of directors as well as any other person engaged to undertake management or control of the applicant or a

medical marijuana treatment center or any person or persons in control of an entity engaged to undertake

management or control of the applicant or medical marijuana treatment center.

(26) Marijuana Oil – Oil derived from marijuana or low-THC cannabis.

(27) MMTC - A medical marijuana treatment center licensed by the department pursuant to s. 381.986(8)(a),

F.S.

(28) Opaque – Not transparent or translucent.

(29)(15) Owner – Any person who, directly or indirectly, owns (actually or beneficially) or controls, a 5% or

greater share of interests of the applicant or a medical marijuana treatment center. In the event that one person owns

a beneficial right to interests and another person holds the voting rights with respect to such interests, then in such

case, both shall be considered the owner of such interests. In determining the owners of the applicant or a medical

marijuana treatment center, the attribution of ownership rules set forth in the Treasury Regulations cited as 26 CFR

1.414(c)-4(b) and (c) (4-1-17 edition), incorporated by reference and available at

https://www.flrules.org/Gateway/reference.asp?No=Ref-09656, shall apply, but with the following exceptions and

additions:

(a) The use of the term “option” in 26 CFR 1.414(c)-4(b) shall be interpreted broadly to include, but not be

limited to, any and all options, warrants, calls, rights of first refusal and any other right to acquire an interest (as

defined herein), whether such right is vested or unvested and regardless of whether such right is then exercisable or

becomes exercisable at a future date or upon the occurrence of a future event.

(b) The exception for attribution of a spouse’s interest, as defined in subsection (12), above, and as set forth in

26 CFR 1.414(c)-4(b)(5)(ii), shall not apply.

(c) The age limitation contained in 26 CFR 1.414(c)-4(b)(6) shall apply only to children who have not attained

the age of 18 years. The term “interest” as used in 26 CFR 1.414(c)-4(b)(6) shall have the meaning as set forth in

subsection (12), above.

(d) In the event that a person under the age of 18 owns or is deemed an owner of an interest, such person must

be disclosed to the department. Persons under the age of 18 shall be required to submit to a background screening

unless the interest or ownership is imputed to another family member or guardian as outlined in paragraph (15)(c),

above.

(e) To the extent that the above alterations to the provisions of 26 CFR 1.414(c)-4 alter the outcome of any of

the examples set forth therein, then, in such case, such example does not apply.

(f) As used in 26 CFR 1.414(c)-4(b)(3), the term “actuarial interest” shall be interpreted broadly and shall

include, but not be limited to, the right of a beneficiary of a trust or an estate to receive either income or principal

distributions with respect to an interest held by such trust or estate.

(g) With regard to publicly traded companies with ownership interests in the applicant, any person who holds

10% or more interest in the publicly traded company shall be considered an owner.

(30) Package – The box, bag, or other vessel that contains the receptacle.

(31) Patient package insert – The information provided to a qualified patient or caregiver inside of the package

of every usable product that contains the information required by s. 381.986(8)(e)12., F.S.

(32) Plain – Black, print lettering, in a sans-serif font, and on a white background with no pictures or graphics

other than one image of the MMTC’s department-approved logo and the universal symbol.

(33)(16) Processing Authorization – Written notification by the department to a medical marijuana treatment

center that it may begin processing marijuana to usable derivative product.

(34)(17) Processing Facility – Any area designated to be used for processing of usable derivative product.

(35) Product name – The brand name and any other name assigned to the usable product.

(36) Receptacle – The container, canister, or material that comes into direct contact with the usable product. In

the case of some derivative products, “receptacle” means the container, canister, or material that comes into direct

contact with the usable derivative product’s immediate covering (e.g., a vape cartridge that contains derivative

product). In the case of edibles, “receptacle” means the container, canister, or material that comes into direct contact

with the individually wrapped edible. Where the usable product is dispensed inside of a marijuana delivery device

(e.g., a vape pen that contains derivative product), the receptacle means the container, canister, or material that

comes into direct contact with the delivery device.

(18) Registration as a Medical Marijuana Treatment Center –Licensure as a medical marijuana treatment center

pursuant to section 381.986(8), F.S.

(37)(19) Resident – A person who meets the requirements of section 381.986(5)(b), F.S.

(38)(20) Routes of Administration – The appropriate method for the usable derivative product to be taken into

the body of the qualified patient, as certified by a qualified physician, but does not include smoking.

(39) Universal symbol – The image available at https://knowthefactsmmj.com/rules-and-regulations/ which is

incorporated by reference.

(40) Usable Product - All forms of marijuana suitable for medical use by a qualified patient.

(41) Usable whole flower marijuana – The flowers of the female cannabis plant, including low-THC cannabis,

that is suitable to be dispensed from an MMTC for use by a qualified patient. Usable whole flower marijuana does

not include seeds, stems, roots, leaves, resin extracted from any part of the plant, or any compound, manufacture,

salt, derivative, mixture, or preparation of the plant or its seeds or resin. Usable whole flower marijuana is not

considered a derivative product.

(42) Written Notice – Notice sent via email to the MMTC’s email address of record if the notice is intended for

the MMTC, or notice sent via email to OMMU at [email protected] if the notice is intended

for the department, unless another means of written notice is specified by rule or statute.

Rulemaking Authority 381.986(8)(b) FS. Law Implemented 381.986 FS. History–New 6-17-15, Amended 9-19-18.

THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A

LATER TIME AND DATE IS SPECIFIED IN THE RULE.

EFFECTIVE 8-26-2020

8. Proposed Rule 64-4.001

Notice of Development of Rulemaking


RULE NO.: RULE TITLE:

64-4.001 Definitions

PURPOSE AND EFFECT: To update the existing definitions rule related to medical marijuana treatment centers in

order to add and update definitions necessary for additional rules being promulgated at this time.

SUBJECT AREA TO BE ADDRESSED: Definitions related to medical marijuana treatment centers

RULEMAKING AUTHORITY: 381.986(8)(k), FS.

LAW IMPLEMENTED: 381.986, FS.

IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE

DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA

ADMINISTRATIVE REGISTER.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY

OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Courtney Coppola (850) 245-4274 or

[email protected].

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

64-4.001 Definitions.

All the terms defined in section 381.986, F.S., shall have the meanings provided in that section, whenever used in

this chapter. For the purposes of Department of Health (the “department”) medical marijuana treatment center rules

and regulations, the following words and phrases shall have the following meanings indicated:

(1) AFRNP - The Applicant Fingerprint Retention and Notification Program authorized by section 943.05(2)(b),

F.S., and established by the Florida Department of Law Enforcement, as provided in Rule 11C-6.010, F.A.C.

(2)(1) Applicant – An individual or entity that meets the requirements of section 381.986(8)(b), F.S., and

applies for licensure registration as a medical marijuana treatment center pursuant to section 381.986(8)(a), F.S.,

excluding subparagraph 1. and sub-subparagraph 2.a.

(3) Arrest Report – The detailed narrative written by the arresting law enforcement officer explaining the

circumstances of the arrest.

(2) through (5) renumbered (4) through (7) No change.

(6) Derivative Product – Forms of marijuana suitable for medical use.


(11) FDLE - The Florida Department of Law Enforcement.

(10) renumbered (12) No change.

(13)(11) Fulfillment and Storage Facility – Any area designated, which is not open to the public, to be used for

order fulfillment, shipping, transportation, or storage of low-THC cannabis, medical marijuana, usable derivative

product or marijuana delivery devices.


(15) Livescan Service Provider - A vendor, entity, or agency authorized by s. 943.053(13), F.S., that scans

fingerprints electronically and submits them to FDLE.


(18) MMTC - A medical marijuana treatment center licensed by the department pursuant to s. 381.986(8)(a),

F.S.,


(20)(16) Processing Authorization – Written notification by the department to a medical marijuana treatment

center that it may begin processing marijuana to usable derivative product.

(21)(17) Processing Facility – Any area designated to be used for processing of usable derivative product.

(18) Registration as a Medical Marijuana Treatment Center –Licensure as a medical marijuana treatment center

pursuant to section 381.986(8), F.S.


(23)(20) Routes of Administration – The appropriate method for the usable derivative product to be taken into

the body of the qualified patient, as certified by a qualified physician, but does not include smoking.

(24) Usable Product - All forms of marijuana suitable for medical use by a qualified patient.

(25) Written Notice – Notice sent via email to the MMTC’s email address of record if the notice is intended for

the MMTC, or notice sent via email to OMMU at [email protected] if the notice is intended

for the department, unless another means of written notice is specified by rule or statute.

Rulemaking Authority 381.986(8)(k)((b) FS. Law Implemented 381.986 FS. History–New 6-17-15, Amended 9-19-18,

____________.

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that on this 24th day of February, 2021 a true and correct copy of the foregoing was furnished to Sarah Young Hodges, Esquire, Chief Appellate Counsel, Office of the General Counsel, 4052 Bald Cypress Way, Bin C-65, Tallahassee, Florida 32399-1703 via email at: [email protected] through the Florida E-Filing Portal constituting compliance with the Florida Rules of Judicial Procedures. Katelyn R. Boswell, Esquire, Chief Appellate Counsel Office of the General Counsel Florida Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1708 Florida Bar # 124413 Telephone: (850) 245-4005 [email protected] Sarah Young Hodges, Esquire, Chief Appellate Counsel Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-1703 Telephone: (850) 354-3367 [email protected] _/S/ Michael C. Minardi___________ MICHAEL C. MINARDI, ESQUIRE MICHAEL MINARDI, P.A. 5301 N. Habana Avenue, Suite 3 Tampa, Florida 33614 Telephone (813) 995-8227 [email protected] Fla. Bar No. 0568619 Counsel for the Appellant

mailto:[email protected]




IN THE DISTRICT COURT OF APPEAL OF THE STATE OF FLORIDA

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